Differential Changes in Ki67 Between Carriers and Noncarriers of BRCA2 Mutations With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-negative Breast Cancer Treated With Preoperative Endocrine Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- assess the change in Ki67
研究概览
简要总结
The researchers are doing this study to look at changes in Ki67 expression after at least 2 weeks of endocrine therapy in people with ER+/HER2- breast cancer undergoing cancer removal surgery. Participants will receive the endocrine therapy before their surgery. The researchers will look at how changes in Ki67 expression compare between participants who are carriers of the BRCA2 mutation and participants who are noncarriers of the BRCA2 mutation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women aged ≥18 years with biopsy-proven stage I-III invasive breast cancer that is ER+/HER2-
- •Scheduled to undergo upfront surgery
- •Eligible for genetic testing in accordance with National Comprehensive Cancer Network guidelines(BRCA2 arm only)
排除标准
- •History of breast cancer
- •Receipt of ET for risk reduction in the previous 3 months
- •Stage IV disease at presentation
- •Scheduled to undergo neoadjuvant systemic chemotherapy
研究组 & 干预措施
Breast Cancer
All study patients will receive standard ET for at least 2 weeks. In accordance with the standard of care, postmenopausal women will receive AI (anastrazole 1mg daily tablet, letrozole 2.5mg daily tablet, or exemestane 25mg daily tablet Which will be followed by standard of care surgical treatment. Surgical tumor tissue will be obtained at the time of surgery and will be assessed for Ki67; a portion of this specimen will be snap-frozen for future analysis. In collaboration with the surgical team, Oncotype can be sent on this research biopsy after pathology assessment. This will enable the patient to receive the Oncotype result and to gain knowledge on the recommendation for adjuvant chemotherapy about 4-6 weeks earlier than our normal workflow. However, if a patient is receiving a clinically indicated, standard of care biopsy after enrolling on this trial, the necessary research samples may be collected during this procedure to avoid an additional research-specific procedure.
干预措施: core needle biopsy (Procedure)
Breast Cancer
All study patients will receive standard ET for at least 2 weeks. In accordance with the standard of care, postmenopausal women will receive AI (anastrazole 1mg daily tablet, letrozole 2.5mg daily tablet, or exemestane 25mg daily tablet Which will be followed by standard of care surgical treatment. Surgical tumor tissue will be obtained at the time of surgery and will be assessed for Ki67; a portion of this specimen will be snap-frozen for future analysis. In collaboration with the surgical team, Oncotype can be sent on this research biopsy after pathology assessment. This will enable the patient to receive the Oncotype result and to gain knowledge on the recommendation for adjuvant chemotherapy about 4-6 weeks earlier than our normal workflow. However, if a patient is receiving a clinically indicated, standard of care biopsy after enrolling on this trial, the necessary research samples may be collected during this procedure to avoid an additional research-specific procedure.
干预措施: blood draw (Other)
结局指标
主要结局
assess the change in Ki67
时间窗: baseline to at least 2 weeks of endocrine therapy
The change in Ki67 expression on immunohistochemical staining from baseline to at least 2 weeks of ET will be assessed.
次要结局
未报告次要终点